In response to public concern, and federal inquiry, stemming from myriad current events involving the oversight of the products it regulates, the FDA has recently developed and issued new regulations, guidance, and procedures to support the agency’s mission to improve the conduct of clinical trials, assess the accuracy and reliability of clinical trial data, and secure the protection of human research participants involved in those trials. This course will address some of the incidents that have led to these new developments, the federal agencies involved in overseeing the FDA, their findings, and how the FDA’s response to the recommendations will impact the conduct of clinical trials.

Describe causal factors and their relation to the current clinical research environment

Examine key areas of concern from Congress, the Office of the Inspector General (OIG), and the General Accounting Office (GAO)

Identify new regulations, guidance, procedures, coalitions, and working groups, and pending and proposed legislation